Incidents with medical devices in the Republic of Latvia are managed in the Medical Device Vigilance system following the requirements described in the Regulation No. 461 of the Cabinet of Ministers of the Republic of Latvia Medical Devices Regulation adopted on August 15, 2023 and Regulation No. 582 In vitro Diagnostic Medical Devices Regulation adopted on October 10, 2023.
The purpose of the vigilance system is to ensure the possibility for the Member States to identify concurrently the model and series of non-conforming medical device in the circulation and use and prevent recurrence of incidents via use of the incident notification system of the users of medical devices in all European Union Member States.
According to the Regulations No. 461 and No. 582 a user of the medical device or responsible person for medical devices shall, within three days after the serious incident, send a signal report to the State Agency of Medicines, and to the manufacturer or the authorized representative and distributor of the medical device as well. The State Agency of Medicines shall follow the investigation procedure of the incident.
A manufacturer of a medical device shall be fully liable for the implementation of the necessary investigation operations in case of the incident regardless of the place of detection and investigation of the incident, ensuring the time record schedule from the time of the notification of the manufacturer. An initial report of the manufacturer regarding the incident with the medical device shall be sent to the State Agency of Medicines of Latvia not later than 15 days after the manufacturer become aware of the incident. A report of the manufacturer regarding a suspected serious incident with the medical device shall be sent to the State Agency of Medicines within the timeline taking account of the severity of the serious incident.
A manufacturer shall, after finishing the investigation, draw up and transfer to the Agency the final report of the investigation. The final report of the investigation of the incident shall be a notification regarding the results obtained and the necessary operations coordinated.
If the investigation process confirms the necessity for corrective actions, the State Agency of Medicines of Latvia shall inform the competent authorities of other European Union Member States and the European Commission.
Report form Manufacturer's Incident Report
Report form Field Safety Corrective Action (FSCA)
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